Bringing down blood pressure early on in patients with acute ischemic stroke did not improve outcomes, a randomized trial showed.

Bringing down blood pressure early on in patients with acute ischemic stroke did not improve outcomes, a randomized trial showed.

The rate of death or major disability at 14 days or hospital discharge was 33.6% in both the patients whose blood pressure was aggressively lowered and those who did not (OR 1.00, 95% CI 0.88-1.14), according to Jiang He, MD, PhD, of Tulane University School of Public Health and Tropical Medicine in New Orleans, and colleagues.

At 3 months, there still wasn't a difference between the two groups (25.2% versus 25.3%; OR 0.99, 95% CI 0.86-1.15), they reported online in the Journal of the American Medical Association. He also presented the results at the American Heart Association meeting in Dallas.

"These findings suggest that unless a patient's blood pressure is greater than 220/120 mm Hg, the decision to lower blood pressure with antihypertensive treatment in patients with acute ischemic stroke should be based on individual clinical judgment," He said at a press briefing.

Although blood pressure reduction has well-known benefits in terms of preventing stroke, the effect of the immediate lowering of blood pressure in the setting of acute ischemic stroke remains unclear. That uncertainty is reflected in current acute stroke guidelines, which provide guidance on blood pressure lowering only for patients receiving thrombolytic therapy and those with markedly elevated readings.

He and colleagues explored the issue in the CATIS trial, which was conducted at 26 centers in China and included 4,071 patients with an imaging-confirmed acute ischemic stroke who presented within 48 hours of symptom onset with an elevated systolic blood pressure (but less than 220 mm Hg). Patients who received thrombolytic therapy were excluded.

The average age of the patients was 62 and the median NIH Stroke Scale score was relatively low at 4. About three-quarters of the patients (77.9%) had stroke of thrombotic subtype.

The patients were randomized to no antihypertensive treatment during the hospital stay or hypertensive treatment with the goal of bringing systolic blood pressure down by 10-25% within the first 24 hours after randomization, getting to a target of less than 140/90 mm Hg within 7 days, and maintaining that level during the rest of the hospitalization.

No specific strategy of blood pressure reduction was mandated, although intravenous enalapril was considered first-line therapy, calcium channel blockers were considered second-line therapy, and diuretics were considered third-line therapies. Clinicians could use a single drug or a combination of agents.

Within the first 24 hours, mean systolic blood pressure dropped from 166.7 to 144.7 mm Hg in the intervention group and from 165.6 to 152.9 mm Hg in the control group. The relative reduction was greater in the intervention group (12.7% versus 7.2%, P<0.001).

The average systolic blood pressure remained lower at 7 days, with a greater proportion of patients in the intervention group achieving the goal of less than 140 mm Hg (65.7% versus 32.2%).

That did not, however, translate into a lower rate of death or major disability (defined as a modified Rankin Scale score of 3 or higher) either at 14 days or discharge or at 3 months.

The findings were generally consistent across subgroups, although at 3 months, there was a significant reduction in death or major disability among the patients who started receiving antihypertensive treatment 24 hours or more after the onset of symptoms (OR 0.73, 95% CI 0.55-0.97).

In the overall study population, recurrent stroke occurred less frequently in the intervention group in the first 3 months, but the difference did not reach statistical significance (1.4% versus 2.2%; OR 0.65, 95% CI 0.40-1.04).

He and colleagues acknowledged that the study was limited by the lack of repeated neurologic function tests and brain imaging during the first 24 hours of blood pressure lowering and by the inclusion of Chinese patients only. Thus, the findings might not apply to Western populations.

The trial was supported by Tulane University and the Collins C. Diboll Private Foundation, both in New Orleans, Soochow University, a Project of the Priority Academic Program Development of Jiangsu Higher Education Institutions, China, and the National Natural Science Foundation of China. The Changzhou Pharmaceutical Factory provided the study drug for the study.